HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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FDA Extends UDI Compliance Deadline for Class 1 Devices
The FDA has extended the UDI compliance deadline for Class 1 and Unclassified devices to September 24, 2020 for both labeling and GUDID submissions. To view the official FDA letter click here. read more →
FDA Posts New Webpage on Use of Symbols in Labeling
The FDA Final Rule on Use of Symbols in Labeling allows the use of symbols without explanatory text. To learn more click here to be taken to the Use of Symbols in Labeling webpage. read more →
European Parliament Votes to Adopt Medical Device Regulation Proposal
On April 5, 2017 the European Parliament adopted two new regulations on medical and in-vitro diagnostic devices. The new EU rules focus on??enhancement of patient safety and the modernization of the overall public health system. To read the official European Commission press release click here. read more →
FDA Grants UDI Extension for Soft Contact Lenses
On March 30, 2017, the FDA released a statement granting a UDI compliance extension for labelers of soft (hydrophilic) contact lenses. To view the extension letter click here. read more →
Malware Alert for HIBCC Clients
It has been brought to our attention that some HIBCC clients are recieving emails from a Madison Brady claiming to be a HIBCC employee. The emails are coming from madisonalbrady@gmail.com and contain a PDF attachment. This individual and email address is in no way associated with HIBCC. Do not open the PDF attachment, as it.. read more →
European Parliament Expected to Adopt Medical Device Regulation (UDI) in April
On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017. To view the EU press release click here. read more →